Medical device registration | Mask production

Certification of mask production equipment

Individual protective masks have become commonplace nowadays, especially in the COVID-2019 outbreak, with demand on these items skyrocketing within months. In quite an anticipated attempt to ramp up production of these new “essentials” the Russian Government introduced a simplified strategy of medical device registration. Currently this procedure takes 5 days, instead of 180! Basically, you obtain registration in advance, with product tests taking place later, but no later than 180 days after the registration.

However, it’s relevant for productions already launched. But if you are only about to start your business you need to be knowledgeable how to put it on a legal footing. Primarily, it’s crucial to know that you are not supposed to license your enterprise, according to the Federal law №99 from 04.05.2011.

Nonetheless, the equipment itself is subject to mandatory certification. This procedure is easy to carry out for an authorized certification center.

Our experts at Open Cert will provide you with all, even subtle details concerning certification of your products or equipment. As regards mask production certification in particular, such equipment is subject to 3 Customs Union Technical Regulations: 004/2011, 010/2011 and 020/2011.

10% Discount
for 2 Documents

GOST-R Certificate

of Conformity

(voluntary) ^?

Price: from 149 Euro

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10% Discount
for 2 Documents

Technical Specifications

on products

Price: from 129 Euro

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10% Discount
for 2 Documents

ISO 9001

Certificate

Price: from 179 Euro

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10% Discount
for 2 Documents

Voluntary

fire safety

certificate ^?

Price: from 199 Euro

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10% Discount
for 2 Documents

Passport

on products

Price: from 59 Euro

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Article in Russian Administative Code	Law Violation	Fine / penalty
14.43	Breaching requirements of the Technical Regulations	from 10 000 up to 20 000 rubles on officials, from 100 000 up to 300 000 rubles on legal entities
14.44	Irregularities in permitting documents	from 15 000 up to 50 000 rubles fine on officials and from 100 000 up to 1 000 000 rubles on legal entities
14.45	Improper selling products that require mandatory certification	from 20 000 up to 40 000 on officials and from 100 000 up to 300 000 rubles on legal entities
14.46	Irregularities in product labelling on products that require mandatory certification	from 10 000 up to 50 000 rubles on officials; from 100 000 up to 1 000 000 on legal entities
14.47	Irregularities in product certification process	from 20 000 up to 50 000 rubles or disqualification for 6 months up to 3 years; from 400 000 up to 1 000 000 on legal entities
14.48	Using false test reports within EAEU certification process	from 30 000 up to 50 000 rubles or disqualification for a year (up to 3 years) on officials; from 400 000 up to 500 000 on legal entities